Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of WT1 LAMP mRNA DC Immunotherapy for Children with High-Grade Glioma and Diffuse Intrinsic Pontine Glioma

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on two types of brain tumors that occur in children: Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG). These are serious conditions that affect the brain and can be challenging to treat. The study is testing a new treatment called WT1 LAMP mRNA DC, which is a type of cell therapy. This treatment involves using special cells called dendritic cells, which are modified to help the immune system recognize and fight the tumor cells. The treatment is given as a suspension for injection, which means it is injected into the skin.

The purpose of the study is to see if this new treatment can be safely produced and given to children with these brain tumors, either alongside their regular treatment or after they have completed other therapies. The study will also look at how safe the treatment is for the patients. During the study, participants will receive the treatment through a series of injections over a period of time. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the new treatment.

Throughout the study, researchers will monitor the patients to see how they respond to the treatment and to check for any side effects. The study aims to understand how the treatment affects the patients' overall health and quality of life. This research is important for finding new ways to help children with these difficult-to-treat brain tumors.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including a diagnosis of high-grade glioma or diffuse intrinsic pontine glioma, being between 12 months and 18 years old, and having a body weight of at least 10 kg.

    The patient or their guardian must provide written informed consent. Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception.

  2. Step 2

    Leukapheresis procedure

    The patient undergoes a procedure called leukapheresis, which involves collecting white blood cells from the blood. This is necessary for the production of the WT1 LAMP mRNA DC vaccine.

  3. Step 3

    Vaccine production

    The collected cells are used to produce the WT1 LAMP mRNA DC vaccine. The goal is to produce at least nine vaccines that meet quality control standards.

  4. Step 4

    Vaccine administration

    The patient receives the vaccine through an intradermal injection, which means it is injected into the skin. The schedule includes multiple doses, with the aim of administering at least nine doses.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, the patient is monitored for any side effects or adverse events related to the vaccine. This includes regular check-ups and assessments to ensure safety and evaluate the vaccine's effects.

    The study also evaluates the patient's response to the vaccine, including any changes in tumor activity and overall health.

  6. Step 6

    Study completion

    The study is expected to continue until September 2025. Upon completion, the patient's overall experience and health outcomes are assessed to determine the feasibility and safety of the vaccine.

Who can join the trial?

9 criteria

  • The patient must have a diagnosis of either High-grade glioma (HGG) or Diffuse intrinsic pontine glioma (DIPG). HGG is a type of brain tumor that is aggressive, and DIPG is a tumor located in a specific part of the brain. The diagnosis can be confirmed by imaging tests like an MRI or by examining tissue samples, although a biopsy is not required.
  • The patient must be at least 12 months old but younger than 18 years at the time of signing the consent form.
  • The patient must weigh at least 10 kilograms.
  • The patient must have a Lansky score of 50 or higher if they are under 16 years old, or a Karnofsky score of 50 or higher if they are 16 years or older. These scores are used to measure the patient's ability to perform daily activities.
  • The patient must have a reasonable life expectancy of at least 8 weeks, as estimated by the doctor treating them.
  • The patient must have adequate blood values and have recovered from any side effects of previous treatments for their brain tumor, as judged by the treating doctor. This applies to a specific group of patients in the study.
  • Written consent must be provided by the patient's parents or legal guardian, and by the patient if they are 12 years or older. For patients younger than 12 years, their consent is optional.
  • The patient must be willing and able to follow the study's rules, as judged by the treating doctor.
  • Female patients who can have children must have a negative pregnancy test before starting the study. Both female and male patients must agree to use effective birth control before, during, and for at least 100 days after the last study treatment. Female patients who are breastfeeding should stop nursing before the first dose of the study treatment and continue to refrain from nursing for at least 100 days after the last treatment.

Who cannot join the trial?

7 criteria

  • Patients who have a medical condition other than Diffuse Intrinsic Pontine Glioma (DIPG) or High-Grade Glioma (HGG) cannot participate. These are specific types of brain tumors.
  • Patients who are not within the age range specified for the study cannot participate. The study is for a specific age group.
  • Patients who are not able to receive the study treatment safely cannot participate. This means if the treatment could harm them, they cannot join.
  • Patients who are not able to follow the study procedures cannot participate. This means if they cannot attend appointments or follow instructions, they cannot join.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of the mother and baby.
  • Patients who have another serious illness that could interfere with the study cannot participate. This means if they have another health problem that could affect the study results, they cannot join.
  • Patients who are taking certain medications that could interfere with the study cannot participate. This means if they are on drugs that might affect the study, they cannot join.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Dendritic Cell Immunotherapy is a type of treatment that uses the body's own immune cells, called dendritic cells, to help fight cancer. In this trial, the therapy is designed to target a specific protein known as WT1, which is found in certain types of brain tumors in children. The goal is to help the immune system recognize and attack the cancer cells more effectively. This therapy is used alongside other standard treatments or after previous therapies to see if it can improve outcomes for patients with high-grade glioma and diffuse intrinsic pontine glioma.

What is already known about the treatment

WT1-targeted DC vaccine – This medication is administered as an injection and is currently being studied in clinical trials for its potential use in treating pediatric patients with high-grade glioma and diffuse intrinsic pontine glioma. The vaccine is designed to work by stimulating the body's immune system to recognize and attack cancer cells, specifically targeting the WT1 protein, which is often present in these types of tumors. It falls under the pharmacological classification of immunotherapy, which uses the body's own immune system to fight cancer. The main therapeutic indications for this vaccine are high-grade glioma and diffuse intrinsic pontine glioma, and it is being evaluated for its feasibility and safety when used alongside conventional treatments like chemoradiation.

Investigated diseases

  • Diffuse Intrinsic Pontine Glioma (DIPG)

    This is a rare and aggressive brain tumor that occurs in the pons, a part of the brainstem. It primarily affects children and is characterized by rapid growth, leading to a range of neurological symptoms. As the tumor progresses, it can cause difficulties with balance, movement, and coordination, as well as problems with vision and swallowing. The tumor's location in the brainstem makes it difficult to treat surgically. DIPG often leads to increased pressure within the skull, contributing to headaches and other symptoms. The progression of the disease can vary, but it typically advances quickly.

  • High-Grade Glioma (HGG)

    This is a type of fast-growing brain tumor that can occur in various parts of the brain. It is known for its aggressive nature and tendency to infiltrate surrounding brain tissue. As the tumor grows, it can cause symptoms such as headaches, seizures, and changes in personality or cognitive function. The tumor's rapid growth can lead to increased pressure in the brain, resulting in additional neurological symptoms. HGGs are often challenging to treat due to their location and aggressive behavior. The progression of the disease can be swift, affecting the patient's quality of life.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2024-515295-12-00Protocol codeADDICT-pedGLIOEstimated enrolment10 patientsSponsorAntwerp University Hospital

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).